The FDA uses technical advisory committees of outside scientific experts to advise it on the approvability of specific products and on the scientific and clinical policy issues it confronts regarding product development and evaluation. The agency also uses these committees to legitimate the soundness of its analysis of a given product, as a public forum for discussion of controversial issues, and, on occasion, as an "appeals court" for disputed agency decisions.*

This chapter recounts the history of FDA advisory committees as it has evolved along somewhat different pathways for drugs, biologics, and medical devices. Variations are due partly to the differences in regulatory responsibilities in these areas and partly to the administrative entities and their cultures. At the end of the chapter, a brief section contrasts FDA advisory committees with the study sections of the National Institutes of Health.

The FDA initiated the use of advisory committees in the 1960s and 1970s for the evaluation of drugs. It extended their use in the early 1970s to the review of biologics soon after the Division of Biological Sciences of the National Institutes of Health was transferred to the FDA as the Bureau of Biologics. Finally, following the Cooper report of 1970, FDA in the early 1970s began to use such committees to classify medical devices, a step that Congress later mandated in the Medical Device Amendments of 1976 for both classification and product evaluation purposes.

DRUGS

The FDA's use of agency-chartered advisory committees for drug evaluation has evolved over the three decades since the 1962** drug amendments to the Food, Drug, and Cosmetic Act. Those amendments required FDA to assess all new drugs for effectiveness, in addition to safety (as required by the 1938 amendments), and to reassess for effectiveness

*  

The FDA does not consider the following to be advisory committees: (1) an internal committee composed exclusively of full-time federal government employees, even if it includes one or two consultants who are special government employees; (2) a group of persons convened on an ad hoc basis to discuss a matter of current interest to the FDA but that has no continuing function or organization and involves no substantial preparation; (3) a group of two or more FDA consultants meeting with the agency on an ad hoc basis; (4) a group of experts employed by a private company or trade association that has been asked by the FDA to provide its views on a regulatory matter before the agency; and (5) a consulting firm hired by the FDA to provide advice on some matter (21 CFR 14.1 (b)(4, 5, & 7), 1991).

**  

In contrast, the use of study sections by the National Institutes of Health began in the period immediately following World War II as that agency's extramural research program came into existence.



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